Manufacturers Voluntarily Recall Infant Cold Meds-Potential Risk of Overdose for kids under 2

FYI

Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines


Potential misuse of these infant medicines, not product safety, is driving the voluntary withdrawal
This withdrawal does not affect cough and cold medicines for children age 2 and older
Further evaluation of these oral cough and cold medicines for infants and children will occur at the October 18 and 19 FDA advisory committee meeting
Washington, D.C.—The Consumer Healthcare Products Association (CHPA) on behalf of the leading makers of over-the-counter cough and cold medicines today announced voluntary market withdrawals of oral cough and cold medicines that refer to "infants." The voluntary withdrawal affects only these "infant" oral medicines, not those intended and labeled for use in children age two and older.

"It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda A. Suydam, D.P.A, president of CHPA. "The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."

The branded cough and cold medicines that are being voluntarily withdrawn are:

Dimetapp® Decongestant Plus Cough Infant Drops
Dimetapp® Decongestant Infant Drops
Little Colds® Decongestant Plus Cough
Little Colds® Multi-Symptom Cold Formula
PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine)
PEDIACARE® Infant Drops Decongestant & Cough (containing pseudoephedrine)
PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
PEDIACARE® Infant Dropper Long-Acting Cough
PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
Robitussin® Infant Cough DM Drops
Triaminic® Infant & Toddler Thin Strips® Decongestant
Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
TYLENOL® Concentrated Infants' Drops Plus Cold
TYLENOL® Concentrated Infants' Drops Plus Cold & Cough
This voluntary withdrawal does not affect medicines intended for children age two and older. CHPA and its member companies have put forth recommendations to the U.S. Food and Drug Administration (FDA) to strengthen the labels on all oral OTC children’s cough and cold medicines from "ask a doctor" before using to "do not use" in children under two years.

CHPA made these recommendations to the FDA in preparation for a joint FDA advisory committee meeting on October 18 and 19. These recommendations, as well as several additional recommendations, including those proposed by FDA review staff, will be explored further at this meeting.

"These medicines are—and always have been—safe at recommended doses," Suydam said.

"These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children’s symptoms. But as with all medicines, it’s important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children."

CHPA will be launching a major, multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations.

More information about the voluntary withdrawal can be found at www.OTCSafety.org.

Note to editors: Images of the group of products being voluntarily withdrawn are available at www.OTCsafety.org.

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CHPA is the 126-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.

www.chpa-info.org

Source

Message edited 10/11/2007 9:23:20 AM.

Re: Manufacturers Voluntarily Recall Infant Cold Meds-Potential Risk of Overdose for kids under 2

I had spoken to our ped because my boys were sick last week and it effects all children under the age of 6 they don want them having any cold medicines.

Re: Manufacturers Voluntarily Recall Infant Cold Meds-Potential Risk of Overdose for kids under 2

Re: Manufacturers Voluntarily Recall Infant Cold Meds-Potential Risk of Overdose for kids under 2

So let me get this straight... the recall is for parents who MAY OD their kids on cough meds?

Re: Manufacturers Voluntarily Recall Infant Cold Meds-Potential Risk of Overdose for kids under 2

Re: Manufacturers Voluntarily Recall Infant Cold Meds-Potential Risk of Overdose for kids under 2

Thanks for posting this. My mom called me to tell me about this recall she heard on the radio.

Re: Manufacturers Voluntarily Recall Infant Cold Meds-Potential Risk of Overdose for kids under 2

I am not worried. I have been giving it to Andrew for over a yr now when he is sick. My ped told me the dosage to give him and I totally trust my ped.

The only reason they are recalling them is to change the directions.